SAR445877

DRUG5 trials

Sponsors

Sanofi-Aventis Recherche & Developpement, Sanofi, M.D. Anderson Cancer Center

Conditions

BevacizimabFOlfox6First Line TreatmentGastric CancerICI-refractoryMetastatic Colorectal Cancer (CRC)Microsatellite StableNon-Small Cell Lung Cancer

Phase 1

A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors

RecruitingNCT05584670

SanofiSolid Tumor

Start: 2022-11-29End: 2028-06-28Target: 542Updated: 2026-06-23

A Phase 1/2, open label, first-in-human, dose escalation and expansion study for the evaluation of safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity of SAR445877 administered as monotherapy or in combination with other anticancer therapies in adults with advanced solid tumors

Not yet recruitingCTIS2023-507141-28-00

Sanofi-Aventis Recherche & DeveloppementSolid tumor

Target: 115Updated: 2025-06-27

Phase 1 Study Of SAR445877 In Combination With FOLFOX6 And Bevacizumab As First-Line Treatment For Microsatellite Stable Metastatic Colorectal Cancer

RecruitingNCT07500298

M.D. Anderson Cancer CenterBevacizimab, First Line Treatment, FOlfox6 +4

Start: 2026-05-20End: 2032-12-27Target: 41Updated: 2026-06-01

Phase 2

A Phase 2 Platform Study of Immunomodulatory Compounds in ICI-refractory Non-small Cell Lung Cancer

RecruitingNCT07133425

M.D. Anderson Cancer CenterICI-refractory, Non-Small Cell Lung Cancer

Start: 2025-11-06End: 2030-02-01Target: 29Updated: 2026-05-20

A Dose Optimization/Expansion Study of SAR445877 in Adult Chinese Participants With Advanced Gastric or Gastroesophageal Junction Cancer

Not yet recruitingNCT07692204

SanofiGastric Cancer, Oesophageal Carcinoma

Start: 2026-07-06End: 2028-08-02Target: 30Updated: 2026-07-09

Related Papers

Abstract CT199: SAR445877: A PD-1-targeted IL-15 mutein selectively activates PD-1+ T cells resulting in therapeutic activity across pre-clinical mouse models and in early human clinical trials

Cancer Research2026-04-17

Initial safety and efficacy results from a first-in-human, phase 1/2 study of SAR445877, an anti-PD-1/IL-15 fusion protein, for patients with advanced solid tumors.

Journal of Clinical Oncology2025-05-28

779 A phase 1/2, open label, first-in-human, dose escalation and expansion study of SAR445877 administered as monotherapy in adults with advanced solid tumors

Regular and Young Investigator Award Abstracts2023-10-312 citations

Abstract 2972: Preclinical characterization of SAR445877, an anti-PD-1 antibody-IL-15 mutein fusion protein with robust anti-tumor efficacy as monotherapy and in combination with PD-L1 blockade

Cancer Research2023-04-041 citations